A Trial to Evaluate the Efficacy and Safety of TNM001 for the Prevention of Lower Respiratory Tract Infection Caused by Respiratory Syncytial Virus in Infants

October 11, 2023 updated by: Zhuhai Trinomab Pharmaceutical Co., Ltd.

A Randomized, Double-blind, Placebo-controlled and Parallel Group Adaptive Phase 2b/3 Trial to Evaluate the Efficacy and Safety of TNM001 Injection for the Prevention of Lower Respiratory Tract Infection Caused by Respiratory Syncytial Virus in Infants Under One Year of Age

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), neutralizing antibody and antidrug antibody (ADA) response for TNM001 in infants entering their first RSV season.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study adopts an adaptive seamless dose selection design and consists of two parts: Part 1 is a phase 2b dose ranging trial which will support to determine the dose for Part 2, the phase 3 trial. The study population includes early and mid-term preterm infants [gestational age (GA)﹤35 weeks 0 day] and late preterm infants or full-term infants (≥35 weeks 0 day GA), with or without Congenital Heart Disease (CHD) or premature infants Chronic Lung Disease (CLD). A total of approximately 2250 infants will be randomized 2:1 to receive either TNM001 or placebo. All subjects will be followed for 240 days after dosing. This study will be conducted in appropriately 50 sites in China.

Study Type

Interventional

Enrollment (Estimated)

2250

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Peking University Third Hospital
        • Contact:
      • Beijing, Beijing, China, 100020
        • Children's Hospital Capital Institute Pediatrics
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China, 400000
        • Jiangjin Central Hospital
        • Contact:
    • Fujian
      • Xiamen, Fujian, China, 361003
        • Xiamen maternal and Child Health Hospital
        • Contact:
    • Guangdong
      • Guangdong, Guangdong, China, 510150
        • The Third Affiliated Hospital of Guangzhou Medical University
        • Contact:
      • Guangzhou, Guangdong, China, 511442
        • Guangdong Maternal and Child Health Care Hospital
        • Contact:
      • Shenzhen, Guangdong, China, 518000
        • University of Chinese Academy of Sciense Shenzhen Hospital
        • Contact:
    • Guangxi
      • Guilin, Guangxi, China, 541001
        • Affiliated Hospital of Guilin Medical University
        • Contact:
      • Liuzhou, Guangxi, China, 545006
        • Liuzhou People's Hospital
        • Contact:
      • Nanning, Guangxi, China, 530002
        • Maternity and Child Health Care of Guangxi Zhuang Autonomous Region
        • Contact:
    • Hainan
      • Haikou, Hainan, China, 570312
        • HaiNan Women and Children's Medical Center
        • Contact:
    • Hebei
      • Langfang, Hebei, China, 065000
        • Hebei Petro China Central Hospital
        • Contact:
      • Shijia Zhuang, Hebei, China, 050000
        • The Fourth Hospital of Hebei Medical University
        • Contact:
      • Shijia Zhuang, Hebei, China, 050000
        • The Second Hospital of HeBei Medical University (HBMU)
        • Contact:
        • Contact:
      • Tangshan, Hebei, China, 063000
        • Tangshan Maternal and Child Health Hospitaltangshan Maternal and Child Health Hospital
        • Contact:
    • Henan
      • Sanmenxia, Henan, China, 472000
        • Sanmenxia Central Hospital
        • Contact:
      • Xinxiang, Henan, China, 453000
        • Xinxiang First People's Hospital
        • Contact:
      • Zhengzhou, Henan, China, 450052
        • Henan (Zhengzhou) Children's Hospital
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Renmin Hospital of Wuhan University
        • Contact:
      • Wuhan, Hubei, China, 430060
        • The Central Hospital of Wuhan
        • Contact:
    • Hunan
      • Changde, Hunan, China, 415000
        • The First People's Hospital of Changde City
        • Contact:
      • Changsha, Hunan, China, 410008
        • Xiangya Hospital Central South University
        • Contact:
      • Changsha, Hunan, China, 410013
        • The Third Xiangya Hospital of Central South University
        • Contact:
      • Changsha, Hunan, China, 410008
        • The Maternal and Child Health Hospital of Hunan Province
        • Contact:
      • Hengyang, Hunan, China, 421001
        • The Second Hospital University of South China
        • Contact:
      • Loudi, Hunan, China, 417099
        • Loudi Central Hospital
        • Contact:
      • Shaoyang, Hunan, China, 422000
        • The First Affiliated Hospital of Shaoyang University
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330000
        • Jiangxi Maternal and Child Health Hospital
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250022
        • Children's Hospital Affiliated to Shandong University
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 201102
        • The affiliated children'shospital fudan university
        • Contact:
    • Shanxi
      • Linfen, Shanxi, China, 041000
        • Linfen People's Hospital
        • Contact:
      • Linfen, Shanxi, China, 041000
        • Linfen Central Hospital
        • Contact:
      • Yuncheng, Shanxi, China, 044000
        • Yuncheng Central Hospital
        • Contact:
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Chengdu Women's and Children's Central Hospital
        • Contact:
      • Chengdu, Sichuan, China, 610000
        • West China Second University Hospital, Sichuan University
        • Contact:
        • Contact:
      • Chongqing, Sichuan, China, 404100
        • Children's Hospital of Chongqing Medical University
        • Contact:
      • Mianyang, Sichuan, China, 621000
        • Mianyang Peoples Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine/Hangzhou First People's Hospital
        • Contact:
      • Ningbo, Zhejiang, China, 315012
        • Ningbo Women&Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 1. Early and mid-term preterm infants (<35 weeks 0 day GA) and late preterm infants or full-term infants (≥35 weeks 0 day GA) under 1 year of age, with or without Congenital Heart Disease (CHD) or premature infants Chronic Lung Disease (CLD)，who are entering their first RSV season at the time of screening.

Exclusion Criteria:

  • 1. Any fever (> 38.0°C) or acute illness within 7 days prior to randomization
  • 2. History of RSV infection or active RSV infection prior to, or at the time of, randomization
  • 3. Drug medication prior to randomization or expected to be treated by medicines during the study period.
  • 4. Currently receiving or expected to receive immunosuppressive therapy during the study period.
  • 5. Renal impairment or hepatic dysfunction
  • 6. Nervous system disease or neuromuscular disease
  • 7. Prior history of a suspected or actual acute life-threatening event
  • 8. Known immunodeficiency including HIV, mother with HIV infection unless the child's infection has been excluded.
  • 9. Known allergy history of immunoglobulin products, receipt or expected to receive immunoglobulins or blood products during the study period.
  • 10.Receipt of RSV vaccine or mAb

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Biological: placebo
single dose intramuscular injection
Experimental: TNM001
Biological: TNM001
single dose intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of medically attended LRTI due to RT-PCR confirmed RSV
Time Frame: 150 days post dose
150 days post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of hospitalization due to RT-PCR confirmed RSV LRTI
Time Frame: 150 days post dose
150 days post dose
Occurrence of adverse events (AEs)
Time Frame: 240 days post dose
240 days post dose
Change in body temperature (celsius)
Time Frame: 240 days post dose
240 days post dose
Change in blood pressure (mmHg)
Time Frame: 240 days post dose
240 days post dose
Change in heart rate (beats per minute)
Time Frame: 240 days post dose
240 days post dose
Change in respiratory rate (breaths per min)
Time Frame: 240 days post dose
240 days post dose
Number of subjects with clinical significant abnormality in physical examinations
Time Frame: 240 days post dose
240 days post dose
Serum concentration of single dose TNM001 at pre-specified timepoints
Time Frame: 240 days post dose
240 days post dose
Serum level of neutralizing antibody to RSV
Time Frame: 240 days post dose
240 days post dose
Positive rate of anti-drug antibody (ADA) to TNM001 in serum
Time Frame: 240 days post dose
240 days post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhuhai Trinomab Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Hanmin Liu, MD, West China Second Hospital, Sichuan University
  • Principal Investigator: Enmei Liu, MD, Children's Hospital of Chongqing Medical University
  • Study Director: Ying Wang, Zhuhai Trinomab Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 6, 2023

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

September 10, 2023

First Submitted That Met QC Criteria

October 11, 2023

First Posted (Actual)

October 16, 2023

Study Record Updates

Last Update Posted (Actual)

October 16, 2023

Last Update Submitted That Met QC Criteria

October 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNM001-301
  • CTR20232792 (Other Identifier: ENTER FOR DRUG EVALUATION, NMPA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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